Agilent Technologies
Senior QSAT Engineer
US-CA-Carpinteria · Senior · Full-time
Sponsorship not specified$125k-$195kDetected 16 days ago
AccessibilityProduct ManagementProcess ImprovementFDA RegulatoryMedical DevicesProblem SolvingGxP
About the role
- This is an expert-level, dual-focused role split approximately 70% product quality (investigations, CAPAs, root cause analysis) and 30% equipment qualification and validation across the product lifecycle.
Responsibilities
- Lead product quality investigations from complaints, post-market surveillance, product quality reviews, and incident trending.
- Drive root cause investigations for product and manufacturing issues using structured problem-solving tools.
- Support R&D compliance during minor design changes and product updates.
- You will partner closely with Manufacturing QA, Field Actions, Vigilance, Post-Market Surveillance, Manufacturing, MSAT, and R&D, and report to the Manager of the QSAT Sustain team.
Requirements
- Proven experience owning CAPA, NCR, and Supplier Corrective Action investigations to timely closure.
- Working knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
- Experience with qualification and validation of production equipment (filling lines, washing machines, or similar).
- 8+ years of quality engineering experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical preferred).
- Strong hands-on root cause analysis and problem-solving skills (Six Sigma, Lean, 5 Whys, Fishbone).
- Ability to interpret and apply risk determinations from FMEAs and related risk documents.
- Ability to review and approve complex CAPA issues to support successful audit outcomes.
- Detail-oriented, process-driven, and effective working cross-functionally.
- Business-level English fluency (read, write, speak).
- Preferred
- Prior QA experience within manufacturing in a regulated industry.
- Familiarity with design control and design transfer.
- Additional Details
Nice to have
- Bachelor's degree in Engineering (advanced degree preferred).
Compensation
- The full-time equivalent pay range for this position is $124,976.00 - $195,275.00/yr plus eligibility for bonus, stock and benefits.
Benefits
- Agilent advances the quality of life by delivering trusted answers and innovative solutions that help our customers improve human health and the world around us.
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This listing is sourced directly from Agilent Technologies's careers page and normalized into a canonical job model.